Omega-3 Fatty Acids to Improve Depression and Reduce Cardiovascular Risk Factors

Completed · Phase 3 · Has a placebo group

Conditions studied: Cardiovascular Diseases, Depression, Heart Diseases, Myocardial Infarction, Angina, Unstable

In brief

This study will determine the effects of omega-3 fatty acid (FA) augmentation of sertraline on depression and cardiac endpoints after myocardial infarction (MI).

Key facts

Study ID

NCT00116857

Run by

Washington University School of Medicine

People needed

122

Starts

2005-02-01

Expected to finish

2009-11-01

Last updated by the study team

2012-09-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets the DSM-IV criteria for a current major depressive episode
• Score of 15 or higher on the Beck Depression Inventory II
• History of acute myocardial infarction, unstable angina, or documented coronary disease

You may not qualify if…

• Physician or patient refusal
• Lives far away from study site
• Current alcohol or drug abuse
• Psychosis, dementia, or bipolar disorder
• Already taking Omega-3
• Medically ill or disabled such that patient is unable to participate
• Comorbid illness likely to be fatal within 1 year of study entry
• Seizure disorder or takes anticonvulsants
• Pregnant or breast feeding
• Liver or kidney disease
• Severe hypertriglyceridemia (greater than 400 mg/dL)
• Bleeding or clotting disorder
• Type 2 diabetes with a hemoglobin A1c (HbA1c) level greater than 10
• Taking lithium or monoamine oxidase inhibitor (MAO-I)

Where it is running

• Washington University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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